GEMFIBROZIL

Product NDC
43602-452
11-digit product format
436020452
Labeler code
43602
Product ID
43602-452_7eda8527-3245-4dbf-b057-af88b97b31ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Ascent Pharmaceuticals, Inc.
Application
ANDA214603
Marketing category
ANDA
Marketing start
2021-01-13
Marketing end
0000-00-00
Substance
GEMFIBROZIL
Active strength
600 mg/1
Pharmacologic classes
Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
931dfe50-414f-e1ab-9c88-b15c4ba31929Product name520210615

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43602-452GEMFIBROZIL TABLET [ASCENT PHARMACEUTICALS, INC.]3Legacy NDC20210116_1c23a180-fe87-4659-80a4-ade059c8f848.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43602-452-10436020452101000 TABLET in 1 BOTTLE (43602-452-10) 1000 tablet2021-01-130000-00-00NoNoCurrent
43602-452-304360204523030 TABLET in 1 BOTTLE (43602-452-30) 30 tablet2021-01-130000-00-00NoNoCurrent